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Medical Devices / Submissions and Approvals

Sonavex’s Blood Flow Monitor Cleared by FDA

March 13, 2019
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Sonavex’s blood flow monitoring device EchoSure received 510(k) clearance from the FDA, allowing surgeons to monitor a patient via a mobile device.

The ultrasound technology “may enable detection of vascular compromise earlier than clinical observation alone, providing opportunities for more rapid intervention and improved patient outcomes,” said Sonavex President and Chief Medical Officer Devin O’Brien Coon.

The device uses deep learning algorithms with 3D ultrasound imaging to visually and quantitatively measure a patient’s blood flow in real-time after microvascular and vascular surgeries.

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